Protocol Life Cycle Subcommittee

Purpose/Mission

Protocol Life Cycle Subcommittee (PLCS) of the Protocol Review Committee (PRC) was established to monitor the scientific progress and accrual of active studies. The subcommittee consists of 6 members in addition to the chair consisting of YCC senior leadership and meets once monthly. Each Disease Aligned Research Team (DART) portfolio is evaluated every 6 months through DART leader presentations that provide the rationale, continued scientific validity, current status for each study, and anticipated time frame for completion for both active and pending studies; particular attention is given to the identification of potentially overlapping trials and prioritization. The Committee also notes the number of studies that are closed but not yet terminated, as these studies require continued regulatory support and resources.

In addition, each trial is reviewed for adequate accrual goals according to the target goals set by the PI. Low accruing studies will generate a letter to the PI asking for an explanation and plan to improve accrual. The PI must then direct the response to the Protocol Life Cycle Subcommittee Chair that stipulates plans for improving accrual rates and study completion timelines. An adequate response may include a change in methods for identifying patients and/or adding collaborating investigators. If there has been no improvement in 3-4 months after initial review, the study may be closed at the discretion of the full PRC based on the PLCS recommendation. Studies in rare, orphan populations or molecular subtypes may be granted additional time to accrue patients per committee discretion.

Modal Title

How will my information be used?

When you express interest in a specific study, the information from your profile will be sent to the doctor conducting that study. If you're eligible to participate, you may be contacted by a nurse or study coordinator.

If you select a health category rather than a specific study, doctors who have active studies in that area may contact you to ask if you would like to participate.

In both cases, you will be contacted by the preferred method (email or phone) that you specified in your profile.